BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    SYMBIS Surgical System

    FDA 510(k)
    FDA Class 2 ·Neurology

    VACCESS LT LONG-TERM HEMODIALYSIS CATHETER PLUS

    FDA UDI
    Bard Access Systems, Inc.·00801741011016·VACCESS PLUS, ST, 16 FR. 42cm

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1430200·Rod Template, 250mm

    Prime Medical LLC

    FDA UDI
    Prime Medical LLC·00850055249288·PrimePadPlus-K14-3422

    RNARETAIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 3, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 27, 2014

    SIGMA 300 DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code DXY·June 29, 2011

    SOLARICE RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code LOX·August 26, 2019

    Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.

    FDA Enforcement
    Class II ·Terminated·Berchtold Corp.·June 15, 2016

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019